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Cardiovascular
Cardiovascular
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Cardiovascular
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Cardiovascular
Biotronik Gets FDA Breakthrough Nod for Freesolve Below-the-Knee Resorbable Magnesium Scaffold
The Freesolve BTK RMS is designed for patients with chronic limb-threatening ischemia (CLTI).
Sam Brusco, Associate Editor
03.18.24
Cardiovascular
FDA Approves Expanded Labeling of Barostim
U.S. annual market opportunity increases based on real-world adoption and strength of long-term BeAT-HF data.
Michael Barbella, Managing Editor
03.12.24
Cardiovascular
Japan's Transcatheter Aortic Valve Replacement Market to Reach $820M in 2033
An aging population, new device approvals, and patient preference for MI procedures are helping drive the country's TAVR market.
Michael Barbella, Managing Editor
03.11.24
Cardiovascular
Bodyport Announces New Data from its SCALE-HF 1 Study
Bodyport's heart failure monitoring technology detected twice as many heart failure events compared to the weight-based standard of care.
Rachel Klemovitch, Assistant Editor
03.08.24
Cardiovascular
Getinge Wins FDA Nod for Vasoview Hemopro 3 Endoscopic Vessel Harvesting
New features include enhanced smoke evacuation, regulated energy control, a game controller-styled handle, and an integrated cable.
Sam Brusco, Associate Editor
03.08.24
Cardiovascular
Silk Road Medical Launches Tapered ENROUTE Transcarotid Stent System
The expansion to the TCAR Portfolio offers additional configurations to tailor the TCAR procedure to patient anatomy.
Rachel Klemovitch, Assistant Editor
03.07.24
Cardiovascular
HeartBeam Granted Two More U.S. Patents
The company now has 14 issued and allowed U.S. patents and four international patents for its VECG technology.
Sam Brusco, Associate Editor
03.07.24
Cardiovascular
Thubrikar Wins Authorization to Expand the TAVI-1 CE Mark Trial in Poland
At less than half the height of commercial self-expanding platforms, the Optimum TAV allows full coronary access.
Michael Barbella, Managing Editor
03.07.24
Cardiovascular
Endotronix Boasts Positive Data for Cordella Pulmonary Artery Sensor
The company's PROACTIVE-HF trial met its primary endpoints at six months.
Sam Brusco, Associate Editor
03.06.24
Cardiovascular
Gradient Starts U.S. Pulmonary Artery Denervation Trial
The Gradient Denervation system ablates nerves around the pulmonary artery using therapeutic ultrasound.
Sam Brusco, Associate Editor
03.06.24
Cardiovascular
|
Diagnostics
|
Software & IT
Cleerly's Coronary Artery Disease Staging System Granted Breakthrough Status
The Cleerly CAD staging system was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot.
Sam Brusco, Associate Editor
03.05.24
Cardiovascular
|
Patient Monitoring
FDA Clears ADI's Sensinel Cardiopulmonary Management System
The compact, wearable device captures cardiopulmonary measurements to manage chronic conditions like heart failure.
Sam Brusco, Associate Editor
03.05.24
Cardiovascular
Getinge CE Certificate for Cardiosave is Temporarily Suspended by TÜV SÜD
Getinge has been given six months to fulfill corrective conditions for the Cardiosave Intra-Aortic Balloon Pump.
Rachel Klemovitch, Assistant Editor
03.05.24
Cardiovascular
BD Begins AGILITY IDE Trial for Vascular Covered Stent
The AGILITY IDE study will assess BD's Vascular Covered Stent to treat peripheral arterial disease.
Sam Brusco, Associate Editor
03.05.24
Cardiovascular
Haemonetics to Buy Attune Medical for $160 Million
Attune Medical is the maker of the ensoETM proactive esophageal cooling device.
Sam Brusco, Associate Editor
03.05.24
Cardiovascular
Vascular Perfusion Solutions Nabs Grant for Pediatric Heart Transplant Preservation Device
Company will use the grant to advance its current VP.S ENCORE cardiac preservation technology into a portable pediatric device.
Michael Barbella, Managing Editor
03.01.24
Cardiovascular
Boston Scientific's Agent Paclitaxel-Coated Balloon Gets FDA OK
The Agent drug-coated balloon showed statistical superiority to uncoated balloon angioplasty in its IDE trial.
Sam Brusco, Associate Editor
03.01.24
Cardiovascular
Argá Medtech Closes €54 Million Oversubscribed Series B Funding
Funding will contribute to advancing US and EU clinical studies for its CSE Pulsed Field Ablation system.
Rachel Klemovitch, Assistant Editor
02.29.24
Cardiovascular
FDA OKs Embolx's Soldier High-Flow Microcatheter
The Soldier microcatheter is used for localized drug delivery in vascular interventions.
Sam Brusco, Associate Editor
02.29.24
Cardiovascular
J&J's Biosense Webster Nabs EU Nod for Varipulse Pulsed Field Ablation
Varipulse’s safety and efficacy were investigated in the inspIRE trial of 186 patients in Canada and Europe.
Sam Brusco, Associate Editor
02.29.24
Breaking News
DirectMed Imaging Acquires Titanium Medical Imaging
SetPoint Medical Receives FDA Breakthrough Device Designation
Siemens Healthineers to Close Fast Track Diagnostics Biz
Sequel's twiist Automated Insulin Delivery System Wins FDA OK
Biotronik Gets FDA Breakthrough Nod for Freesolve Below-the-Knee Resorbable Magnesium Scaffold
View Breaking News >
CURRENT ISSUE
March 2024
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
The Sweet Science of Diabetes Technology
View More >